Reforming the Food, Drug, and Cosmetic Act to Reflect Our Constitutional Rights and Modern Medicine

One major reform that would greatly ameliorate the FDA regulatory barriers that prevent the translation of modern research into practical products and that greatly slow the development of life extension technology would be to eliminate the Kefauver Amendments of 1962. Before 1962, the FDA was responsible for certifying safety, but once a drug was determined to be safe to use in a certain dose range, physicians and patients, along with scientists and clinicians doing research on the drug, determined over time what the drug was efficacious in treating. As noted in a recent issue of Regulation,1 Daniel B. Klein and Alexander Tabarrok argue, “In a sense, off-label uses are regulated according to the pre-1962 rules, under which the FDA held new drugs only to safety requirements, whereas on-label uses are regulated according to the post-1962 rules.” Thus, they say, “Off-label prescribing tells us something about how the world might look if the FDA were restricted to safety-testing alone.” Yet this is an understatement. The amount of innovation if the FDA certified only safety would increase dramatically, since the costs of getting FDA approval would decrease from about $800,000,000 per drug to roughly $50,000,000 per drug. It would allow many small and medium-sized companies rather than just a few very large companies to develop and market new drugs, and drug prices could be expected to be much lower than they are under the current FDA regulatory regime.

In fact, the inherent roadblock imposed by the FDA’s post-1962 efficacy rules has been noted in the scientific literature. In the July 2004 Neurodegeneration,2 for example, an article notes in a discussion of FDA regulatory reform that “Before 1962, the only requirement for drug approval was to show that a drug was safe in humans. Since that time, demonstration of drug efficacy in phase 2 and phase 3 clinical trials has been required. A relaxation of the current emphasis on ‘proof’ of efficacy, stopping short of eliminating all efficacy trials, would stimulate drug-discovery efforts. It is important to remember that the great majority of drugs approved before 1962 were concluded to be effective after careful retrospective analysis of clinical data. In fact, many drugs that were retroactively denied approval in the aftermath of the 1962 change might actually have been effective.”

Amazingly, there has been a bold bill introduced into the House of Representatives (HR2544) by Congressman Dana Rohrabacher (R-CA) that includes a provision to strike the effectiveness requirement (post-1962 Kefauver Amendments) of the Food, Drug, and Cosmetic Act. This bill also allows imports of drugs from anywhere so long as they do not violate valid U.S. patents and provided that they meet FDA composition and purity standards for the same drug when made in the United States. Note that this bypasses the FDA’s expensive and unreasonable drug GMPs; how the foreign manufacturer makes the drug is irrelevant so long as it meets composition and purity standards. We enthusiastically support this pioneering legislation and hope that others will contact their Congresscritter to ask them to be cosponsors (at present, the bill has none). It is likely that after the upcoming election, Congressmen may be more willing to stick their necks out for an FDA reform effort that increases, rather than decreases, freedom of informed choice.